Senior Group QA Lead - GMP & Quality Systems

Octapharma; Wien; Hybrid; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

Octapharma is seeking a Group Lead Expert (m/f/d) for Pharmaceutical Quality System. The role will be based in Vienna or other European sites and demands extensive GMP expertise across multiple sites and regions.

You will lead harmonisation of the Pharmaceutical Quality System, drive global procedures, and oversee cross-site quality initiatives with a strong emphasis on deviations, CAPA, and investigations. Travel 5–10 times per year within Europe is expected.

Qualifikationen

• 10+ years of QA experience in pharmaceutical manufacturing, with extensive experience overseeing GMP quality systems, manufacturing operations, and quality organizations across Europe and the US.
• University degree in Chemistry, Chemical Engineering, Pharmacy, or a comparable scientific field
• Proven experience leading cross-site quality initiatives and harmonising pharmaceutical quality processes
• Strong expertise across deviations, CAPA, Change Control, investigations, validation, SOPs and continuous improvement processes, with experience across biologics, sterile products
• Strong stakeholder management skills, with the ability to build trust and drive collaboration across sites, cultures and Quality teams
• Audit experience is desirable but not required; however, an interest in developing further in this area is important
• Willingness to travel 5–10 times per year, mainly within Europe

Aufgaben

• Act as Group Subject Matter Expert for GMP regulations and guidelines, advising Octapharma sites on GMP-related topics
• Monitor evolving GMP regulations, assess their impact and communicate relevant changes through Quality Bulletins
• Lead the development and harmonisation of the Pharmaceutical Quality System, including global procedures and templates
• Participate in and support intersite audits of manufacturing and packaging sites
• Coordinate Group Quality activities, including the annual mock recall and regular alignment with local Quality Assurance teams

Kenntnisse

GMP regulations

Quality System

Cross-site leadership

CAPA & Deviations

Change Control

Investigations

SOPs

QA processes

Stakeholder management

Travel willingness

Ausbildung

University degree in Chemistry

Chemical Engineering

Pharmacy

Science field

Jobbeschreibung

Octapharma is seeking a Group Lead Expert (m/f/d) for Pharmaceutical Quality System. The role will be based in Vienna or other European sites and demands extensive GMP expertise across multiple sites and regions.

You will lead harmonisation of the Pharmaceutical Quality System, drive global procedures, and oversee cross-site quality initiatives with a strong emphasis on deviations, CAPA, and investigations. Travel 5–10 times per year within Europe is expected.